TRISCEND JAPAN Trial
Phase 3
Recruiting
- Conditions
- Severe or greater TR
- Registration Number
- JPRN-jRCT2022220045
- Lead Sponsor
- Morino Yoshihiro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 45
Inclusion Criteria
Symptomatic tricuspid regurgitation (TR) despite medical therapy
- TR graded as severe or greater
- Appropriate for transcatheter tricuspid valve replacement per the local heart team
Exclusion Criteria
- Tricuspid valve anatomic contraindications
- Need for emergent or urgent surgery or any planned cardiac surgery within the next 12 months
- Hemodynamic instability
- Refractory heart failure requiring advanced intervention
- Currently participating in another investigational study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Two co-primary endpoints<br>- All-cause mortality (1-year post procedure)<br>- Heart failure hospitalization (1-year post procedure)
- Secondary Outcome Measures
Name Time Method